My role as Head of Product Development is to lead and support all design and development activitiesfor the company's medical devices. This role is crucial in ensuring the successful delivery of innovative and high-quality products that meet both market needs and regulatory requirements.My duties are:° Oversee and coordinate the entire product development process, from concept to commercialization with all relevant external stakeholder and internal team members.° In charge of organizing, preparing and leading design reviews in collaboration with Quality and Regulatory Affairs Department° Ensure products are designed in compliance with medical device regulations and standards.° Responsible in defining needs of new subcontractors and preparing necessary documents that define collaboration: QA agreement, services agreement, consultancy agreement, or non-disclosure agreement, in collaboration with the CTO and QAM.° Responsible to ensure appropriate implementation and the provision of Design & Development Procedure.° Responsible to ensure that technical documentation activities are performed by internal or external resources with sufficient knowledge and experience and as per Good Practices established internally.° Write and review documents related to design and development activities, such as test protocols and reports and verification protocols and reports, in collaboration with the C-Level and R&D Team.

° Responsible for Developing and implementing the company's technology roadmap° Define company strategy and objectives with Board of Directors and C-Level° Overseeing the development of new products and services° Building and leading the technology teamIn summary, as the CTO, my mission is to foster a culture of trust, open-mindedness, and creativity within a high-performing team. I will drive the development of technological solutions that align with the company's overall mission and objectives while ensuring regulatory compliance

° Setting-up the strategy, roadmap, and vision for the directSTIM product line° Secured CE-mark for Class III AIMD as a result of extraordinary teamwork of highly skilled, passionate and healthy team members° Involved with submission of Design Dossier to notified body for CE-approval° Passionate Leader of skilled cross-functional engineering, marketing, sales, and support teams° Responsible for Design Control, Development and V&V activities° Owner of directSTIM DBS System Development and Verification Planning° Coordinating with Manufacturing and Operations for DVT needs° Project Management with US partner° Responsible for animal stereotactic surgeries and follow-up° Writing of Verification and Validation Master Plans, reviewing of verification protocols° Strong implication with Risk Management and Risk Analyses° Responsible for acute and chronic studies on big animals (over 60 surgeries performed)° Good knowledge of ISO-13485/10993/14708/60601/14155/62304/62366

° Responsible for Design and Development of a MDD class III Intra-Surgical Multiple Electrode Lead for Deep Brain Stimulation (DBS) surgeries in Movement Disorders.° Construction of a clinical Dossier and interaction with ethics committee and Swiss agency for authorization and market supervision of all therapeutic and medical products.° Project Manager of ALEVAs first medical device as legal manufacturer to be used for human trials in CH° Lead of all DVT testing and elaboration of tools. Interaction with subcontracted labs for Biocomp and sterility testing° Responsible for technical assistance during clinical studies in Surgical OR

° Device Validation Testing (DVT) and preliminary design/concept studies° In-vivo long-term studies and in-vitro long-term testing° Responsible for animal stereotactic surgeries and follow-up° Writing and reviewing of verification protocols and plans° European FELASA cat. C certificate

Involved in:° Quality Management System implementation° Clinical affairs and product verification & validation° Writing of protocols and reports° Conducting preliminary and approved tests° Developing custom tools for specific tests.

Development of external BiVADs (Bi Ventricular Assists Devices) based on artificial muscles. Physiologic muscle movement is reproduced using SMAs (Shape Memory Alloys)

Development, optimization and quality control of artificial urinary devices.

Micro and Nano-systems engineer, Master degree achieved with the help of Prof. Renaud and his lab LMIS4.

Our first aim was to create an interface where the consumption of a given actuatorcould be calculated as a function of the muscle wire length and the input power necessary tooperate any medical implantable system using SMAs. In addition we also integrated theevaluation of the operative duration of two different commercially available implantablebatteries as a function of the calculated consumption of the system.

Clean room experience. Fabrication of solar cells.